This analysis of the TRINITY study (Triple Therapy with
Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide in
Hypertensive Patients Study) also demonstrated that the
investigational triple combination therapy (40/10/25 mg) enabled
more patients with hypertension and diabetes to achieve blood
pressure goal of <130>

Approximately 70 percent of people with diabetes have high blood
pressure,(3) which puts them at greater risk of developing
long-term complications such as cardiovascular and renal
disease.(2) In order to achieve recommended blood pressure control
of <130>

About 15.5 percent (387 of 2,492) of the entire patient
population of the TRINITY study were hypertensive patients with
diabetes, and were thus included in this subgroup analysis.(1) In
these patients, the triple combination therapy was well tolerated
with most reported adverse events defined as mild or moderate in
severity.(1)

"In addition to taking medications to treat high blood pressure,
patients with diabetes often need to take several other medications
to ensure glucose and cholesterol levels also are within
recommended target levels," said Suzanne Oparil, MD, Professor of
Medicine and Physiology and Biophysics at the University of Alabama
School of Medicine. "Therefore, having a blood pressure-lowering
treatment option that combines three medications into one pill will
likely help patients take all of their medications as prescribed.
Results of this subgroup analysis are important because it shows
that this investigational triple combination therapy can help some
of the most challenging patients significantly lower their blood
pressure."

Two additional pre-specified subgroup analyses of the TRINITY
study by ethnicity (Hispanic/Latino or non-Hispanic/Non-Latino) and
body mass index (BMI) category of <30 kg>

It is estimated that hypertension affects 21 percent of Hispanic
adults (18 years or older) in the U.S.(5) Additionally, the
majority of patients with high blood pressure are overweight, with
the condition being six times more frequent in obese people.(6)

Results for the ethnicity subgroup analysis [Hispanic or Latino
(n=369, 14.8 percent) and non-Hispanic or non-Latino (n=2,122)]
showed that the olmesartan medoxomil / amlodipine /
hydrochlorothiazide (40/10/25 mg) triple combination therapy
produced a significantly greater mean reduction in seated diastolic
blood pressure (P less than or equal to 0.0236) and a greater
reduction in seated systolic blood pressure from baseline to week
12 compared with each dual combination therapy regardless of
ethnicity.(4) Additionally, in both non-obese patients (n=937, BMI
of <30 kg>

Additionally, in both the ethnicity and BMI subgroups of the
study, the triple combination of olmesartan medoxomil / amlodipine
/ hydrochlorothiazide (40/10/25 mg) resulted in a greater
percentage of patients reaching blood pressure goal compared with
each dual combination group.(4) The incidence of treatment-emergent
events in the BMI and ethnicity subgroup analyses was comparable
between groups and adverse events were mild or moderate.(4)

TRINITY Study Design

At total of 2,492 patients with moderate to severe hypertension
were enrolled into the Phase 3, multicenter, randomized,
double-blind, parallel-group study, which examined the safety and
efficacy of the triple combination of olmesartan medoxomil /
amlodipine / hydrochlorothiazide (40/10/25 mg).(1,4) Patients were
randomized to receive one of three dual combination therapies
(n=2,456) or placebo (n=36) for the first two weeks of the study:
olmesartan medoxomil (40 mg) / amlodipine (10 mg); olmesartan
medoxomil (40 mg) / hydrochlorothiazide (25 mg); or, amlodipine (10
mg) / hydrochlorothiazide (25 mg).(1,4) After the first two weeks,
until week four, the 36 patients on placebo were switched to one of
the dual combination therapies.(1,4) At four weeks, a subset of
patients from each of the three dual combination groups were
switched to the triple combination therapy of olmesartan (40 mg) /
amlodipine (10 mg) / hydrochlorothiazide (25 mg) and continued for
12 weeks (n=627).(1,4) The 12 week double-blind treatment period
was followed by a 40 week open-label treatment period.(1,4) The
12-week results were presented at the American Society of
Hypertension (ASH) annual meeting earlier this year, which found
that the blood pressure-lowering and percentage of patients
reaching the current recommended blood pressure target was greater
with the triple combination therapy (40/10/25 mg) versus
corresponding dual combination therapy regardless of gender, age,
race, and hypertension severity (P<0.0001).(7)

Safety & Tolerability

Across all groups, drug-related treatment adverse events (TEAEs)
were reported in 25.4 percent of patients.(1) Most TEAEs and
drug-related TEAEs were mild or moderate in severity.(1) More
discontinuations due to TEAEs occurred in the olmesartan medoxomil
/ amlodipine / hydrochlorothiazide (40/10/25 mg) (4.0 percent)
versus the dual combination therapy groups (1.0 to 2.1 percent) and
were due to adverse events such as dizziness and hypotension.(1)
These discontinuations can potentially be attributed to the more
pronounced pharmacodynamic effect of the triple combination
therapy.(1) Peripheral edema also was a cause for
discontinuation.(1)

In addition, discontinuations for patients on triple combination
therapy also included subjects who experienced an adverse event on
earlier treatment (i.e. placebo or dual), prior to initiation of
the triple combination regimen.(1)

About The Triple Combination Therapy

A fixed-dose, single combination product of olmesartan
medoxomil/ amlodipine / hydrochlorothiazide is currently under
review for approval with the US Food and Drug Administration (FDA)
for the treatment of hypertension.

About Daiichi Sankyo

The Daiichi Sankyo Group is dedicated to the creation and supply
of innovative pharmaceutical products to address the diversified,
unmet medical needs of patients in both mature and emerging
markets. While maintaining its portfolio of marketed
pharmaceuticals for hypertension, hyperlipidemia, and bacterial
infections, the Group is engaged in the development of treatments
for thrombotic disorders and focused on the discovery of novel
oncology and cardiovascular-metabolic therapies. Furthermore, the
Daiichi Sankyo Group has created a "Hybrid Business Model," which
will respond to market and customer diversity and optimize growth
opportunities across the value chain. For more information, please
visit www.daiichisankyo.com.

Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey,
is a member of the Daiichi Sankyo Group. For more information on
Daiichi Sankyo, Inc., please visit www.dsi.com.

(2) U.S. Department of Health and Human Services, National
Institutes of Health, National Heart, Lung, and Blood Institute.
The Seventh Report of the Joint National Committee on Prevention,
Detection, Evaluation, and Treatment of High Blood Pressure. NIH
Publication No. 04-5230. August 2004.

(6) Poirier P, et al. Obesity and Cardiovascular Disease:
Pathophysiology, Evaluation, and Effect of Weight Loss: An Update
of the 1997 American Heart Association Scientific Statement on
Obesity and Heart Disease From the Obesity Committee of the Council
on Nutrition, Physical Activity, and Metabolism. Circulation.
2006;113: 898 - 918.

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